ISO 21535: Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint implants
ISO 21535 has been fundamentally revised. It now references all testing standards for hip implants, including the relevant ASTM procedures. In addition, it describes how the test results are to be evaluated in a multi-stage procedure. In particular, the described use of a reference implant presents manufacturers with fundamentally new requirements.
Our specialists will be happy to assist you in selecting the worst-case products to be tested and in developing a test plan that meets the requirements of ISO 21535.